NCT00816673

Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Neurim Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

Detailed description

Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy. The aim of this placebo controlled study was to investigate the effect of 2 mg Melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	placebo Circadin	Placebo tabs of Prolonged release melatonin
DRUG	Circadin	prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks

Timeline

• Start date: 1996-09-01
• Primary completion: 1997-05-01
• Completion: 1997-09-01
• First posted: 2009-01-05
• Last updated: 2024-11-14

Locations

1 site across 1 country: France